Adapted Physical Activity for Breast Cancer HER2 Positive Patient (APACAN2)
Primary Purpose
HER2 Positive Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Home-based Adapted Physical Activity
Sponsored by
About this trial
This is an interventional supportive care trial for HER2 Positive Breast Cancer focused on measuring Breast cancer, HER2+, Adapted physical activity, Neoadjuvant chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Women > 18 years old
- Patient with HER2 (Human Epidermal growth factor Receptor 2) positive breast cancer histologically proven, eligible for neoadjuvant chemotherapy and targeted therapy against HER-2
- Affiliation to the French social security scheme
- Patient who signed the participation consent before entering the trial
- Medical fitness certificate for sport
Exclusion Criteria:
- Diagnosis of a second malignancy in the past 5 years, with the exception of a basal cell skin cancer
- Metastatic cancer
- Karnofsky index ≤ 90%
- Men
- Pregnant women
- Significant psychiatric or neurological abnormality
- Patient deprived of liberty by a court or administrative
- Contraindication for physical activity
- Patient unable to complete questionnaires (language barrier)
- Participation in a clinical trial with the same objective
Sites / Locations
- Centre Jean PerrinRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional
Arm Description
Home-Based Adapted Physical Activity intervention during neoadjuvant chemotherapy : 150 minutes per week of aerobic and muscle strengthening exercises during 18 weeks
Outcomes
Primary Outcome Measures
Rate of patients reaching international physical activity recommendations for post-neoadjuvant chemotherapy assessment
Time spent to physical activity and sedentariness will be evaluated by Recent Physical Activity Questionnaire (RPAQ)
Secondary Outcome Measures
Longitudinal evolution of RPAQ score
Quality of life : Quality of Life Questionnaire-C30
Asthenia : Multidimensional Fatigue Inventory-20
Anthropometrics measurements
BMI
Anthropometrics measurements
Hip circumference (cm)
Physical capacity : six-minutes walking distance test
Physical capacity : Voluntary muscular strength
Physical capacity : VO2max
This measure is optional
Lipid profile : total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Ventricular ejection fraction assessed by echocardiography or cardiac scintigraphy
Changes of cancer treatment
frequency of dose reduction (%), of postponement (%) or of treatment discontinuation (%)
Assessment of physical activity level using a validated smartphone application (eMouveRecherche)
Including sedentariness time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02963363
Brief Title
Adapted Physical Activity for Breast Cancer HER2 Positive Patient
Acronym
APACAN2
Official Title
Feasibility Study of an Adapted Physical Activity (APA) for Breast Cancer Patients Treated by Neoadjuvant Chemotherapy and Targeted Therapy Against HER2
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2018 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the feasibility of a home-based adapted physical activity during neoadjuvant chemotherapy for HER2+ breast cancer.
Detailed Description
After the assessment of their physical fitness, a home-based adapted physical activity program composed by aerobic and muscle strengthening exercises will be delivered to each patient. The aim of the intervention is to reach international recommendation in a progressive way during neoadjuvant chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2 Positive Breast Cancer
Keywords
Breast cancer, HER2+, Adapted physical activity, Neoadjuvant chemotherapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
Home-Based Adapted Physical Activity intervention during neoadjuvant chemotherapy :
150 minutes per week of aerobic and muscle strengthening exercises during 18 weeks
Intervention Type
Other
Intervention Name(s)
Home-based Adapted Physical Activity
Intervention Description
Home-based adapted physical activity to attend progressively 150 minutes of physical activity per week at the end of neoadjuvant chemotherapy.
5 times 30 minutes of walking + 3 times 30 minutes of muscle strengthening exercises per week during 18 weeks
Primary Outcome Measure Information:
Title
Rate of patients reaching international physical activity recommendations for post-neoadjuvant chemotherapy assessment
Description
Time spent to physical activity and sedentariness will be evaluated by Recent Physical Activity Questionnaire (RPAQ)
Time Frame
Change from baseline (T0: before neoadjuvant chemotherapy) at the 5 months (T1: end of neoadjuvant chemotherapy)
Secondary Outcome Measure Information:
Title
Longitudinal evolution of RPAQ score
Time Frame
Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Title
Quality of life : Quality of Life Questionnaire-C30
Time Frame
Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Title
Asthenia : Multidimensional Fatigue Inventory-20
Time Frame
Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Title
Anthropometrics measurements
Description
BMI
Time Frame
Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Title
Anthropometrics measurements
Description
Hip circumference (cm)
Time Frame
Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Title
Physical capacity : six-minutes walking distance test
Time Frame
Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Title
Physical capacity : Voluntary muscular strength
Time Frame
Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Title
Physical capacity : VO2max
Description
This measure is optional
Time Frame
Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Title
Lipid profile : total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Time Frame
Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Title
Ventricular ejection fraction assessed by echocardiography or cardiac scintigraphy
Time Frame
Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Title
Changes of cancer treatment
Description
frequency of dose reduction (%), of postponement (%) or of treatment discontinuation (%)
Time Frame
At each cycle of neoadjuvant chemotherapy : every three weeks during 5 months
Title
Assessment of physical activity level using a validated smartphone application (eMouveRecherche)
Description
Including sedentariness time
Time Frame
Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women > 18 years old
Patient with HER2 (Human Epidermal growth factor Receptor 2) positive breast cancer histologically proven, eligible for neoadjuvant chemotherapy and targeted therapy against HER-2
Affiliation to the French social security scheme
Patient who signed the participation consent before entering the trial
Medical fitness certificate for sport
Exclusion Criteria:
Diagnosis of a second malignancy in the past 5 years, with the exception of a basal cell skin cancer
Metastatic cancer
Karnofsky index ≤ 90%
Men
Pregnant women
Significant psychiatric or neurological abnormality
Patient deprived of liberty by a court or administrative
Contraindication for physical activity
Patient unable to complete questionnaires (language barrier)
Participation in a clinical trial with the same objective
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angeline GINZAC
Phone
33463663337
Email
Angeline.Ginzac@clermont.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie THIVAT
Phone
33473278089
Email
Emilie.Thivat@clermont.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier DURANDO, MD
Organizational Affiliation
Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier DURANDO, MD
Phone
33463663337
Email
Xavier.Durando@clermont.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Xavier DURANDO, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
34966667
Citation
Ginzac A, Bernadach M, Molnar I, Duclos M, Thivat E, Durando X. Adapted Physical Activity for Breast Cancer Patients Treated with Neoadjuvant Chemotherapy and Trastuzumab Against HER2 (APACAN2): A Protocol for a Feasibility Study. Front Oncol. 2021 Dec 13;11:744609. doi: 10.3389/fonc.2021.744609. eCollection 2021.
Results Reference
derived
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Adapted Physical Activity for Breast Cancer HER2 Positive Patient
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